Ovarian Cancer Clinical Trial

Mirena® IUD’s Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation

Summary

Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular method of contraception, but it is not known if its use will reduce a woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release sufficient progestin to also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against IEOC.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Women between 35 and 50 years of age (inclusive)
Women who will be scheduled to undergo an RRSO or RRs
Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)

Exclusion Criteria:

Any medical contraindication to use of a Mirena® IUD, including:

Pregnancy (a pregnancy test is required prior to study entry)
Known uterine anomaly that distorts the shape of the uterine cavity
Acute pelvic inflammatory disease
Postpartum endometritis or endometrial infection
Known or suspected uterine or cervical neoplasia
Known history or suspected breast cancer or other progestin-sensitive cancer
Uterine bleeding of unknown etiology.
Untreated acute cervicitis, vaginitis, or other lower genital tract infections
Acute liver disease or liver tumor (benign or malignant)
Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
Positive pregnancy test
Breastfeeding
Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

7

Study ID:

NCT02477202

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 5 Locations for this study

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Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Commack
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre New York, , United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

7

Study ID:

NCT02477202

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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